MQA Specialist – 3rd Shift
Indivior
August 12, 2026
On-site
Raleigh, NC
Operations
Responsibilities:
- Provide quality oversight for all critical manufacturing processes; make independent quality decisions.
- Address daily quality concerns for operating/environmental issues; communicate complex issues to management.
- Review in-process batch records, resolve batch issues, and complete timely final batch record approvals to meet release schedules.
- Complete gown qualification and maintain aseptic area entry status; demonstrate aseptic gowning knowledge.
- Perform aseptic gown training and certification sampling.
- Identify deviations and ensure proper initiation by appropriate personnel.
- Assess aseptic behavior; provide real-time aseptic coaching and risk mitigation for technique violations.
- Conduct viable/nonviable environmental monitoring in aseptic and classified manufacturing/support rooms.
- Collect facility waters for testing; requisition materials, maintain inventory, receive/store prepared media; enumerate bacteria and report excursions if required.
- Ensure compliance with local/state/federal rules; support cGMP compliance and continuous improvement.
- Develop knowledge of regulatory requirements (21 CFR Parts 210/211, cGMP, FDA, OSHA, etc.).
Qualifications/Requirements:
- Bachelor’s degree in science/engineering or equivalent experience.
- Minimum 1 year pharmaceutical industry experience in a cGMP environment with aseptic technique.
- Ability to get gown certified within 30 days.
- Physical ability to stand/walk up to 8 hours (4 hours at a time in aseptic area), lift/move up to 35 lbs, and climb/balance/stoop/kneel/crouch/crawl up to 1 hour.
- Good oral/written communication and interpersonal skills; acceptable visual acuity test.
Benefits (as stated):
- Competitive PTO; bonus eligibility; 401(k) with company match; medical/dental/vision/life/disability; tuition reimbursement; and other listed benefits.
- Provide quality oversight for all critical manufacturing processes; make independent quality decisions.
- Address daily quality concerns for operating/environmental issues; communicate complex issues to management.
- Review in-process batch records, resolve batch issues, and complete timely final batch record approvals to meet release schedules.
- Complete gown qualification and maintain aseptic area entry status; demonstrate aseptic gowning knowledge.
- Perform aseptic gown training and certification sampling.
- Identify deviations and ensure proper initiation by appropriate personnel.
- Assess aseptic behavior; provide real-time aseptic coaching and risk mitigation for technique violations.
- Conduct viable/nonviable environmental monitoring in aseptic and classified manufacturing/support rooms.
- Collect facility waters for testing; requisition materials, maintain inventory, receive/store prepared media; enumerate bacteria and report excursions if required.
- Ensure compliance with local/state/federal rules; support cGMP compliance and continuous improvement.
- Develop knowledge of regulatory requirements (21 CFR Parts 210/211, cGMP, FDA, OSHA, etc.).
Qualifications/Requirements:
- Bachelor’s degree in science/engineering or equivalent experience.
- Minimum 1 year pharmaceutical industry experience in a cGMP environment with aseptic technique.
- Ability to get gown certified within 30 days.
- Physical ability to stand/walk up to 8 hours (4 hours at a time in aseptic area), lift/move up to 35 lbs, and climb/balance/stoop/kneel/crouch/crawl up to 1 hour.
- Good oral/written communication and interpersonal skills; acceptable visual acuity test.
Benefits (as stated):
- Competitive PTO; bonus eligibility; 401(k) with company match; medical/dental/vision/life/disability; tuition reimbursement; and other listed benefits.